The small, filigree parts can save children’s lives – but they are scarce: clinics have problems ordering some specialized medical products, such as balloon catheters and stents for children. Doctors warn that there is also a shortage of other important tools, such as certain scalpels, endoscopes or heart valves. According to these critics, the main reason for this is an EU law, the new Medical Devices Regulation. On Friday, the Commission responded to months of pressure from associations and MEPs and proposed transitional periods for the to extend legislation.
The EU Parliament and the Council of Ministers, the legislative chambers of the member states, still have to approve the changes; this is to be done in an accelerated process. Health Commissioner Stella Kyriakides said “a number of circumstances” had “put health systems across the EU at risk of shortages of life-saving medical devices”. The proposed adjustments should ensure that “in the short term, any risk of shortages is reduced and access is guaranteed for the patients most dependent on these products”.
Behind the quarrels is the tightening of the Medical Devices Ordinance. That was already decided in 2017, as a lesson from the scandal surrounding inferior breast implants in Germany and France. But the stricter rules have only been in effect since 2021. The law requires manufacturers to re-register their medical devices by May 2024 or they will not receive the necessary one CE mark, proving that the goods meet EU standards. But this new registration is time-consuming, expensive and time-consuming – it takes between 13 and 18 months. It is therefore not possible to recertify all products by 2024.
Some providers also decide that the effort for niche products is not worth it. Sooner or later the goods will disappear from the market. A survey of the German Chamber of Industry and Commerce and other associations among 378 companies showed that in 16 of the 21 product groups surveyed, at least half of the companies were eliminating individual products or even entire ranges: for example in orthopedics or surgical instruments.
Companies were “not adequately prepared,” they say
Another problem is that there are too few notified bodies. That’s the name of the test facilities that the corporations have to contact for approval, such as Tüv Süd. The EU regulation also requires notified bodies to be re-certified before they are allowed to test under the tightened rules. However, this is dragging on, so far only 36 institutions have managed to do this across the EU – and they are now unable to keep up with the work.
The Commission is therefore now proposing to give manufacturers more time for certification. Many companies “have not prepared themselves adequately,” complains the Brussels authorities. The deadline is to be extended from May 2024 to December 2027, for low-risk goods such as syringes even to the end of 2028. In addition, the existing approval of products should not expire automatically; So hospitals don’t have to throw away scarce catheters just because it’s been so long since certification.
The CSU MEP Angelika Niebler, co-chair of the CDU/CSU in the Strasbourg Parliament, calls the Commission’s initiative “an important step towards more patient safety” in the EU: “Our months of pressure on the Commission to tackle the problem is finally over successfully.”